Statin and Post-interventional Coronary Microcirculation Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01751295
Recruitment Status : Unknown
Verified December 2012 by Jin-Ho Choi, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
Jin-Ho Choi, Samsung Medical Center

Brief Summary:
The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI Not Applicable

Detailed Description:

Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.

In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
Study Start Date : December 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: atorvastatin
PCI with atorvastatin pre-treatment group
Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI
Other Name: lipinon
No Intervention: control
PCI without atorvastatin pre-treatment group

Primary Outcome Measures :
  1. Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel [ Time Frame: within 1 year after PCI ]

Secondary Outcome Measures :
  1. Post-procedural troponin I [ Time Frame: within 1 year after PCI ]
  2. Post-procedural FFR [ Time Frame: within 1 year after PCI ]
  3. Post-procedural IMR comparison of target vessel with non-target vessel [ Time Frame: within 1 year after PCI ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A. Finished informed consent
  • B. Stable angina with clinical indication of coronary angiography
  • C. Age ≥ 21 year and ≤ 80 year

Exclusion Criteria:

  • A.Without informed consent
  • B.PCI target lesion is not adequate or not indicated for FFR/IMR study
  • C.Prior myocardial infarction or interventional procedure for PCI target vessel
  • D.Myocardial infarction within 30 days
  • E.Usage of statin, current or within 1 month
  • F.Prior bypass surgery
  • G.Impaired renal function (Creatinine > 2.0 mg/dL)
  • H.Impaired left ventricular function (ejection fraction < 40%)
  • I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN)
  • J.Contraindication for long-term antiplatelet agent or statin
  • K.Planning or potential of pregnancy
  • L.Neoplastic disease without evidence of treatment completion
  • M.Impaired general condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01751295

Korea, Republic of
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Jin-Ho Choi, professor, Samsung Medical Center Identifier: NCT01751295     History of Changes
Other Study ID Numbers: 2012-08-052
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors